Tobacco Cessation in Postmenopausal Women

NCT ID: NCT01210586

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31
• Study Completion Date: 2008-01-31

Brief Summary

This study investigated whether being on transdermal hormone replacement therapy (HRT) influenced smoking cessation variables in postmenopausal women undergoing short-term abstinence from cigarettes. Women were recruited into two groups according to their pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT group had their prior medication replaced with a standard 0.1 mg estradiol transdermal system and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment, participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks, participants were instructed to quit smoking. They were provided with smoking cessation counseling and monitored for abstinence. Data were collected during five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal Scale, Beck Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and Reaction Time Test.

Part II is identical to Part I, except it randomizes participants to use nicotine patch or not.

Conditions

HRT; Non-HRT; Continued Smoking; Smoking Abstinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nicotine Patch

Nicotine Patch for Smoking Cessation

Group Type: ACTIVE_COMPARATOR

Part 2

Intervention Type: BEHAVIORAL

Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.

Placebo Patch

Group Type: PLACEBO_COMPARATOR

Part 2

Intervention Type: BEHAVIORAL

Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.

Interventions

Part 2

Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 40-79 years old
• Clinical Menopause
• > 15 cigarettes per day for at least one year
• Experienced nicotine withdrawal based on DSM IV

Exclusion Criteria

• Currently obtaining nicotine from other sources
• Abnormal vaginal bleeding
• unstable health
• history of stroke or embolism
• history of abnormal thyroid function
• significant skin disorders
• active psychiatric disease

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon S Allen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Other Identifiers

2002NT050

Identifier Type: -

Identifier Source: org_study_id